Peritoneal dialysis system including a water treatment device

ABSTRACT

A peritoneal dialysis system is disclosed. An example peritoneal dialysis system includes a water treatment device including a water treatment processor and a first memory and a peritoneal dialysis (“PD”) machine including a PD processor and a second memory. The PD machine is configured to mix water treated by the water treatment device with at least one concentrate to produce a peritoneal dialysis fluid for treatment. The example peritoneal dialysis system also includes a data link between the water treatment processor and the PD processor. The water treatment device is configured to prepare an amount of treated water and, upon communication between the water treatment processor and PD processor over the data link, deliver the amount of the treated water to the PD machine for use in mixing the peritoneal dialysis fluid for the treatment. The treated water has a purity corresponding to an injectable quality or a sterile quality.

PRIORITY CLAIM

This application claims priority to and the benefit as a continuationapplication of U.S. patent application Ser. No. 13/828,822, filed Mar.14, 2013, entitled, “Control of a Water Device via a Dialysis MachineUser Interface”, which is a continuation-in-part application of U.S.patent application Ser. No. 13/494,259, filed Jun. 12, 2012, entitled,“Dialysis System Including Multi-Heater Power Coordination” (now U.S.Pat. No. 8,419,933), which is a continuation application of U.S. patentapplication Ser. No. 13/030,909, filed Feb. 18, 2011, entitled,“Dialysis System Including Multi-Heater Power Coordination” (now U.S.Pat. No. 8,216,452), which is a continuation application of U.S. patentapplication Ser. No. 12/031,605, filed Feb. 14, 2008, entitled,“Dialysis System Including Multi-Heater Power Coordination” (now U.S.Pat. No. 7,892,423), the entire contents of each of which areincorporated herein by reference and relied upon.

BACKGROUND

The present disclosure relates generally to renal therapy systems andmore specifically to systems and methods for controlling a watertreatment device solely or only through a dialysis device.

Due to disease, insult or other causes, a person's renal system canfail. In renal failure of any cause, there are several physiologicalderangements. The balance of water, minerals and the excretion of dailymetabolic load is no longer possible in renal failure. During renalfailure, toxic end products of nitrogen metabolism (urea, creatinine,uric acid, and others) can accumulate in blood and tissues.

Kidney failure and reduced kidney function have been treated withdialysis. Dialysis removes waste, toxins and excess water from the bodythat would otherwise have been removed by normal functioning kidneys.Dialysis treatment for replacement of kidney functions is critical tomany people because the treatment is life saving. One who has failedkidneys could not continue to live without replacing at least thefiltration functions of the kidneys.

Hemodialysis and peritoneal dialysis are two types of dialysis therapiescommonly used to treat loss of kidney function. Hemodialysis treatmentuses the patient's blood to remove waste, toxins and excess water fromthe patient. The patient is connected to a hemodialysis machine and thepatient's blood is pumped through the machine. Catheters or needles areinserted into the patient's circulatory system to connect the blood flowto and from the hemodialysis machine. Blood and dialysate are passedthrough a dialyzer in the hemodialysis machine. The dialyzer can includea semi-permeable membrane separating the blood and the dialysate. Asblood passes through a dialyzer in the hemodialysis machine, thedialyzer removes the waste, toxins and excess water from the patient'sblood. In particular, the toxins are moved osmotically from the bloodacross the membrane into the dialysate. The hemodialysis machine returnsthe blood back to the patient. A large amount of dialysate, for exampleabout one-hundred twenty liters, is used to dialyze the blood during asingle hemodialysis treatment. The spent dialysate is then discarded.Hemodialysis treatment lasts several hours and is generally performed ina treatment center about three or four times per week.

Peritoneal dialysis uses a dialysis solution or “dialysate”, which isinfused into a patient's peritoneal cavity through a catheter implantedin the cavity. The dialysate contacts the patient's peritoneal membranein the peritoneal cavity. Waste, toxins and excess water pass from thepatient's bloodstream through the peritoneal membrane and into thedialysate. The transfer of waste, toxins, and water from the bloodstreaminto the dialysate occurs due to diffusion and osmosis, i.e., an osmoticgradient occurs across the membrane. The spent dialysate drains from thepatient's peritoneal cavity and removes the waste, toxins and excesswater from the patient. This cycle is repeated.

There are various types of peritoneal dialysis therapies, includingcontinuous ambulatory peritoneal dialysis (“CAPD”), automated peritonealdialysis and continuous flow peritoneal dialysis. CAPD is a manualdialysis treatment, in which the patient connects an implanted catheterto a drain and allows a spent dialysate fluid to drain from theperitoneal cavity. The patient then connects the catheter to a bag offresh dialysate and manually infuses fresh dialysate through thecatheter and into the patient's peritoneal cavity. The patientdisconnects the catheter from the fresh dialysate bag and allows thedialysate to dwell within the cavity to transfer waste, toxins andexcess water from the patient's bloodstream to the dialysate solution.After a dwell period, the patient repeats the manual dialysis procedure.

In CAPD the patient performs several drain, fill, and dwell cyclesduring the day, for example, about four times per day. Each treatmentcycle typically takes about an hour. Manual peritoneal dialysisperformed by the patient requires a significant amount of time andeffort from the patient. This inconvenient procedure leaves ample roomfor improvement and therapy enhancements to improve patient quality oflife.

Automated peritoneal dialysis (“APD”) is similar to CAPD in that thedialysis treatment includes a drain, fill, and dwell cycle. APDmachines, however, automatically perform three to four cycles ofperitoneal dialysis treatment, typically overnight while the patientsleeps. The APD machines fluidly connect to an implanted catheter. TheAPD machines also fluidly connect to a source or bag of fresh dialysateand to a fluid drain.

The APD machines pump fresh dialysate from the dialysate source, throughthe catheter, into the patient's peritoneal cavity and allow thedialysate to dwell within the cavity so that the transfer of waste,toxins and excess water from the patient's bloodstream to the dialysatesolution can take place. The APD machines then pump spent dialysate fromthe peritoneal cavity, though the catheter, to the drain. APD machinesare typically computer controlled so that the dialysis treatment occursautomatically when the patient is connected to the dialysis machine, forexample, when the patient sleeps. That is, the APD systems automaticallyand sequentially pump fluid into the peritoneal cavity, allow for adwell, pump fluid out of the peritoneal cavity and repeat the procedure.

As with the manual process, several drain, fill, and dwell cycles willoccur during APD. A “last fill” is typically used at the end of APD,which remains in the peritoneal cavity of the patient when the patientdisconnects from the dialysis machine for the day. APD frees the patientfrom having to manually performing the drain, dwell, and fill steps.

For patients suffering from renal diseases, frequent dialysis is a wayof life. Most peritoneal dialysis patients perform dialysis once a day.Hemodialysis patients typically require dialysis several times a week.To allow patients to continue to live their lives as normally aspossible, there has been an increased desire to provide home dialysissolutions. Peritoneal dialysis is typically performed at home.Hemodialysis and other blood treatment therapies, such ashemofiltration, are performed largely in centers and clinics.

Performing dialysis, whether hemodialysis or peritoneal dialysis, athome presents more challenges and complexities for patients. Typically,dialysis is performed using a dialysis device and a fluid source. Thefluid source may be provided in one or more prepared solution bag or beprepared online via a water treatment device and concentrated additives.In the case of the water treatment device, the dialysis machine and thewater treatment device are operated at the same time to successfullyperform a therapy. Operating two machines or devices can be difficult,especially for elderly patients or immobile patients who may not be ableto easily and quickly observe and/or manipulate both devices. Viewingand/or entering information on or into the two devices may prove to becumbersome. Both the dialysis machine and the water treatment devicewill produce data that may be desirable to store for analysis. The datashould be accurate, timely and provide a sufficient level of detail.

A need accordingly exists for a home dialysis system that integrates awater treatment device with a hemodialysis machine, such that control ofboth machines or devices is centralized, and such that data may flowreadily to and from both machines or devices.

SUMMARY

The system and method of the present disclosure integrate the operationof a dialysis machine and a water treatment device, such that the userin essence operates the water treatment device from the dialysismachine. That is, the user interface for the water treatment device isthe user interface that controls the dialysis machine. The watertreatment device can have its own small user interface but primarycontrol of the water treatment device is via the dialysis machine. It isalso contemplated to transfer data from both machines to a centralrepository maintained by a therapy provider, provide reports oftreatment data concerning both the machine and the device to clinicians,integrate with billing and ordering systems, track consumables usage anddeliver consumables as needed, and service and maintain the machines ona network of the system. To this end, in one embodiment the dialysismachine is in data fluid communication with the water treatment devicevia Ethernet or other wired communication. The dialysis machine is inturn in communication with the system or network. In this manner, datafrom the water treatment device can be sent via the dialysis machine tothe network or system. The system or network can likewise send operatinginstructions and software upgrades via the dialysis machine to the watertreatment device.

The dialysis machine includes a home therapy machine, such as, but notlimited to, a home hemodialysis (“HD”) machine, a home peritonealdialysis (“PD”) machine, a home hemofiltration (“HF”) machine, a homehemodiafiltration (“HDF”) machine, and a home continuous renalreplacement (“CRRT”) machine. While renal therapy is one focus of thepresent disclosure, the present disclosure also contemplates theintegration of any home fluid delivery therapy, such as in addition, ahome drug delivery therapy or a nutritional therapy. In variousembodiments, the home therapy is any type of therapy using a medicalfluid that can be made online, or at the time of use beginning with asource of purified water, such as ultrapure water as that term isunderstood in the art. For example, while PD has typically beenperformed using bagged dialysate, it is contemplated to instead makeonline PD solution beginning with the source of ultrapure or sterilewater and adding PD concentrates, such as dextrose or glucoseconcentrate, as needed.

It is also contemplated that the home therapy is a nutritional therapyin which purified water from the water treatment device is used as thebase for preparing a nutritional solution that is delivered to thepatient. In any situation, all the control of the water treatment deviceis maintained through the same user interface that is used to controlthe home therapy machine, in one embodiment, be it a blood treatmenthome therapy machine, a PD home therapy machine or a nutritional hometherapy machine.

It is contemplated for the home medical device system to transfertreatment prescriptions to the home therapy machine. A doctor'sprescription for a renal or other type of home therapy is created. Aclinician can remotely select, based upon the doctor's prescription,supplies to send to the patient's home, including supplies for both thehome therapy machine and the water treatment device. The clinician canalso remotely set operating parameters for operating both the hometherapy machine and the water treatment device. The operating parametersfor both the machine and device are sent to the home therapy machine.The operating parameters for the home therapy machine are stored in thememory of the therapy machine. The operating parameters for the watertreatment device are forwarded from the home therapy machine to thewater treatment device and stored in the memory of the water treatmentdevice.

The system and method of the present disclosure also allow for theupgrading of firmware on the home therapy machine and the watertreatment device via the home therapy machine. When upgraded firmware isgenerated, the firmware is sent to the home therapy machine. If the newfirmware is meant for the home therapy machine, the new firmware isinstalled on the home therapy machine. If the new firmware is meantinstead for the water treatment device, the home therapy machineforwards the new firmware to the water treatment device, where it isinstalled. In certain jurisdictions, it may be required that the useraccept the software upgrade, be it for either the home therapy machineor the water treatment device. In either case, it is contemplated toallow the user to accept the new firmware, for either the machine or thedevice, at the user interface for the home therapy machine.

It is contemplated to provide operating prescriptions and new firmwarewith tags that designate which of the home therapy machine and the watertreatment device is to receive the operating instructions or thefirmware. Alternatively, the instructions and firmware may inherentlylook or have content that is peculiar to either the home therapy machineor the water treatment device. In this latter case, the home therapymachine can determine whether to itself accept the instructions orfirmware upgrade or to forward same to the water treatment device basedon the detected inherent characteristics. No additional tag is neededhere.

Based on the foregoing and following description, it should beappreciated that it is an advantage of the present disclosure to providean improved home therapy treatment using online purified watergeneration.

It is another advantage of the present disclosure to provide an improvedhemodialysis, hemofiltration, hemodiafiltration, peritoneal dialysis,drug delivery, and nutritional home therapy system and method.

It is a further advantage of the present disclosure to provide animproved system and method for sending operating parameters to multiplemachines or devices of a home therapy system.

It is yet another advantage of the present disclosure to provideclinicians, doctors and nurses with the ability to remotely review andmonitor data produced by multiple machines or devices cooperating toprovide a home therapy.

It is yet a further advantage of the present disclosure to provide animproved system and method for sending firmware upgrades to multiplemachines or devices cooperating to provide a home therapy.

It is still another advantage of the present disclosure to ensure thatdata sent back and forth between a server and multiple machines ordevices cooperating to provide a home therapy is performed in a reliableand secure manner.

It is still a further advantage of the present disclosure to preventdata from being delivered from a server to multiple machines or devicescooperating to perform a home therapy while the machines or devices arebeing operated.

Moreover, it is an advantage of the present disclosure to allow a userto control aspects of a treatment involving multiple machines or devicesusing one user interface.

Additional features and advantages are described herein and will beapparent from the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1A is a schematic block diagram of one embodiment of a home medicaldevice system of the present disclosure.

FIG. 1B is a block diagram of one embodiment of a computing device usedin the home medical device system of the present disclosure.

FIG. 2 is a block diagram of one embodiment of a dialysis machine with awater purification unit in a home medical device system of the presentdisclosure.

FIG. 3 is a schematic view of one embodiment of a subsystem including awater treatment device in communication with a home therapy machine fora home medical device system of the present disclosure.

FIG. 4 is a flowchart of an example process of the present disclosurefor installing a water treatment device.

FIG. 5 is a flowchart of an example process of the present disclosurefor making water with a water treatment device.

FIG. 6 is a flowchart of an example process of the present disclosurefor starting up a home therapy machine and a water treatment device.

FIG. 7 is a flowchart of an example process of the present disclosurefor updating a component in a water treatment device.

FIG. 8 is a flowchart of an example process of the present disclosurefor shipping inventory and programming a therapy prescription for a hometherapy machine and/or a water treatment device based upon an approvedtreatment prescription.

FIG. 9 is a flowchart of an example process of the present disclosurefor upgrading firmware on a home therapy machine and/or a watertreatment device.

FIG. 10A is a screen shot of an example dashboard screen for a clinic ofthe present disclosure.

FIG. 10B is a screen shot of an example legend for a dashboard screen ofthe present disclosure.

FIG. 11A is a screen shot of an example treatment summary screen of thepresent disclosure.

FIG. 11B is another screen shot of an example treatment summary screenof the present disclosure.

FIG. 12 is a screen shot of an example patient usage report of thepresent disclosure.

DETAILED DESCRIPTION Home Medical Device System

Referring now to the drawings and in particular to FIG. 1A, a homemedical device system 110 is illustrated. System 110 shows a hometherapy machine 100, which can be of any type including a homehemodialysis (“HD”), home hemofiltration (“HF”), home hemodiafiltration(“HDF”), home peritoneal dialysis (“PD”), home drug delivery, ornutritional home therapy machine. If home therapy machine 100 is a homehemodialysis machine, one suitable machine is set forth in U.S. PatentPublication No. 2009/0101549, entitled, “Modular Assembly For AHemodialysis System”, filed Aug. 27, 2008, the entire contents of whichare incorporated herein by reference and relied upon.

While a single home therapy machine 100 is illustrated as communicatingwith a connectivity server 118, system 110 oversees the operation of aplurality of home therapy machines 100, of the same type or of differenttypes. For example, there may be M number of hemodialysis machines 100,N number of hemofiltration machines 100, O number of hemodiafiltrationmachines 100, P number of peritoneal dialysis machines 100, Q number ofhome drug delivery machines 100, and R number of nutritional hometherapy machines 100 connected to server 118 and operating with system110. The numbers M through R may be the same or different numbers, andmay be zero, one, or more than one.

In the illustrated embodiment, home therapy machine 100 receives at itsfront end purified water from a water treatment device 10. One suitablewater treatment device 10 is set forth in U.S. Patent Publication No.2011/0197971, entitled, “Water Purification System And Method”, filedApr. 25, 2011, the entire contents of which are incorporated herein byreference and relied upon. In one embodiment, water treatment device 10outputs ultrapure water as that term is understood in the art. Theultrapure water may be passed through one or more filter, such as anultrafilter or a dialyzer to make the water of or near an injectable ordrug quality. The injectable quality water may then be mixed with one ormore dry, liquid, or slurried concentrate to produce (i) an injectablesubstitution solution for HF or HDF, (ii) a PD solution, (iii) a drugfor infusion or (iv) a nutritional solution for infusion.

System 110 illustrates that home therapy machines 100 operates withother devices besides water treatment device 10, such as a bloodpressure monitor 104, a weigh scale, e.g., wireless weigh scale 106, anda wireless tablet user interface 122. Home therapy machine 100 connectsto server 118 wirelessly in one embodiment via a modem 102. Each ofthese components, including water treatment device 10, are generallylocated within the patient's home, as demarcated by the dashed lines inFIG. 1A. Any one, or more or all of components 10, 104, 106 and 122 maycommunicate wired or wirelessly with home therapy machine 100. Wirelesscommunication may be via Bluetooth™, WiFi™, Zigbee®, Z-Wave®, wirelessUniversal Serial Bus (“USB”), infrared, or any other suitable wirelesscommunication technology. Alternatively, any one, or more or all ofcomponents 10, 104, 106 and 122 can communicate with home therapymachine 100 via wired communication.

In one embodiment, water treatment device 10 connects to home therapymachine 100 via an Ethernet cable. Water treatment device 10 is poweredunder its own power in one embodiment. Home therapy machine 100 canrequest water as needed from water treatment device 10. Water treatmentdevice 10 is sized and configured to supply, on an online or batchbasis, any amount of water that machine 100 needs.

Connectivity server 118 communicates with much of home medical devicesystem 110 via a home medical device system hub 120. System hub 120enables data and information concerning each home therapy machine 100and water treatment device 10 on system 110 to travel back and forth viathe connectivity server 118 between the machines 100 and the otherclients connected to server 118. In the illustrated embodiment, systemhub 120 is connected to a service portal 130, an enterprise resourceplanning system 140, a web portal 150, a business intelligence portal160, a HIPAA compliant database 124, a product development team 128 andelectronic medical records databases 126 a to 126 n.

The electronic medical records (“EMR”) databases 126 a to 126 n containelectronic information about patients. The system hub 120 can send thedata collected from log files of machine 100, described in detail below,to hospital or clinic databases 126 a to 126 n to merge or supplementthat patient's medical records. Databases 126 a to 126 n may containpatient-specific treatment and prescription data and therefore access tosuch databases could be highly restricted. The enterprise resourceplanning system 140 obtains and compiles data generated via the patientand clinician website access, such as complaints, billing informationand life cycle management information. Web portal 150 enables patientsand clinics 152 a to 152 n treating the patients to access a publiclyavailable website for system 110. Business intelligence portal 160collects data from the system hub 120 and provides data to marketing162, research and development 164, and quality/pharmacovigilance 166.

System Block Diagram

A block diagram of one embodiment for the electrical systems of any ormore or all of the machines, devices or subsystems of the home medicaldevice system (e.g., water treatment device 10, machine 100, modem 102,blood pressure monitor 104, scale 106, server 118, system hub 120, userinterface 122, service portal 130, enterprise resource planning system140, web portal 150, business intelligence portal 160) is illustrated inFIG. 1B. System 110, including any or all of devices or subsystems 10,100, 102, 104, 106, 118, 120, 122, 130, 140, 150, and 160, includes amain unit 170 which in one embodiment includes one or more processor 176electrically coupled by an address/data bus 178 to one or more memorydevice 174, other computer circuitry 172, and one or more interfacecircuit 180. Processor 176 may be any suitable processor, such as amicroprocessor from the INTEL PENTIUM® family of microprocessors. Memory174 may include volatile memory and non-volatile memory. Memory 174 canstore one or more software program that interacts with the other devicesin the system 110 as described below. Memory 174 may also store digitaldata indicative of documents, files, programs, web pages, etc. retrievedfrom another computing device and/or loaded via an input device 194.

The interface circuit 180 may be implemented using any suitableinterface standard, such as an Ethernet interface and/or a USBinterface. One or more input device 194 may be connected to theinterface circuit 180 for entering data and commands into the main unit170. For example, input device 194 may be a keyboard, mouse, touchscreen, track pad, track ball, isopoint, and/or a voice recognitionsystem. Interface circuit 180 may be connected to any type of network182, such as an Internet, a local area network (“LAN”), a telephonenetwork (POTS), and/or other networks.

One or more displays, printers, speakers, and/or other output devices192 may also be connected to the main unit 170 via the interface circuit180. Display 192 may be a cathode ray tube (CRT's), liquid crystaldisplays (LCD's), or any other type of display. Display 192 generatesvisual displays of data generated during operation of the device orsubsystem 10, 100, 102, 104, 106, 118, 120, 122, 130, 140, 150, and/or160. For example, display 192 may be used to display informationreceived from the system hub 120. The visual displays may includeprompts for human input, run time statistics, calculated values, data,etc.

One or more storage device 190 may also be connected to the main unit170 via the interface circuit 180. For example, a hard drive, CD drive,DVD drive, and/or other storage devices may be connected to the mainunit 170.

It should be appreciated that the disclosed methods and proceduresdescribed herein may be implemented using one or more computer programsor components. These components may be provided as a series of computerinstructions on any conventional computer-readable medium, includingrandom access memory (“RAM”), read only memory (“ROM”), flash memory,magnetic or optical disks, optical memory, or other storage media. Theinstructions may be configured to be executed by a processor, which whenexecuting the series of computer instructions performs or facilitatesthe performance of all or part of the disclosed methods and procedures.

Data Transfer for the Water Treatment Device

In one embodiment, home therapy machine 100 performs a home treatment,such as home hemodialysis on a patient at the patient's home and thenreports the results of that treatment to clinicians, doctors and nurseswho are responsible for managing the health and well-being of thatpatient. The results of the treatment include data that is supplied fromwater treatment device 10 to home therapy machine 100. Water treatmentdevice 10 data can include, for example, total volume of waterdelivered, quality of water delivered (e.g., chlorine content), how manydifferent times water treatment device 10 delivered water to therapymachine 100 over the course of a treatment (this data could be monitoredby device 10 or machine 100), average flowrate of the water delivered,any alarms or alerts that water treatment device 10 experienced over atreatment, and/or an amount of time or number of cycles performed overthe course of a treatment, e.g., for component replacement information.

Home therapy machine 100 writes log files using, e.g., a Linux™operating system. The log files again document pertinent home therapymachine 100 data and pertinent water treatment device 10 data over thecourse of a treatment. The log files may include any one or more ofExtensible Markup Language (“XML”), comma-separated values (“CSV”) ortext files. The log files are placed into a file server box of thesoftware of home therapy machine 100. It is contemplated to store dataat water treatment device 10 that is not sent to machine 100. Such datamay otherwise be obtained via the Ethernet data connection to watertreatment device 10 or downloaded through other data connections orstorage media. For example, a service person can access additional datavia a laptop connected to water treatment device 10 via the Ethernetconnection. Or, the additional data may be retrieved remotely from watertreatment device 10, with home therapy machine 100 serving as the datatransfer liaison between water treatment device 10 and authorized systemclients as described herein.

Home therapy machine 100, e.g., via the Internet, uses a connectivityservice to transfer data, including water treatment device 10 data,between modem 102 and system hub 120. In one embodiment, a dedicatedline is provided at each patient's home for connecting the home therapymachine 100 to the connectivity server 118 via modem 102. Home therapymachine 100 in one embodiment accesses the Internet using a separate,e.g., 3G, 4G or 5G, modem 102. Modem 102 uses an Internet ServiceProvider (“ISP”), such as Vodafone™. In one implementation, aconnectivity agent 114 developed by a connectivity service provider(e.g., provider of connectivity server 118) is installed onto the hometherapy machine 100 and run on primary control processor (“ACPU”) 112.One suitable connectivity service is provided by Axeda™. Theconnectivity service provides a secure managed connection 116 betweenmedical devices and the connectivity server 118.

The connectivity agent 114 allows the home therapy machine 100 toconnect to connectivity server 118 and transfer data, including watertreatment device 10 data, to and from the connectivity server 118. Theconnectivity service operating via agent 114 and server 118 ensures thatthe connection with machine 100 is secure, ensures that the datacorrectly passes through machine 100′s firewalls, checks whether therehas been a data or system crash and checks whether and ensures that theconnectivity server 118 is communicating with the correct home therapymachine 100.

In one embodiment, home therapy machine 100 can only connect to theconnectivity server 118 when connectivity agent 114 is turned on. Duringtreatment and post-treatment disinfection, while machine 100 and watertreatment device 10 are functioning, connectivity agent 114 is turnedoff. This prevents the home therapy machine 100 from communicating withany entity and sending or receiving data during treatment anddisinfection or when machine 100 is live or running When the hometherapy machine 100 is idle, e.g., after treatment and post-disinfectionis complete, ACPU 112 turns connectivity agent 114 on. In oneembodiment, connectivity agent 114 is off only during treatment(including pretreatment). Connectivity agent 114 then retrieves the logfiles from the home therapy machine 100 and transfers data, includingwater treatment device 10 data, to the connectivity server 118 using theconnectivity service. The connectivity service routes data packets totheir proper destination but in one embodiment does not modify, access,or encrypt the data.

In system 110 of FIG. 1A, the connectivity service via connectivityserver 118 can communicate data to various places via a system hub 120,a service portal 130 and a web portal 150. Connectivity server 118allows service personnel 132 a to 132 n and/or clinicians to track andretrieve various assets across the network, such as appropriate hometherapy machines 100 and 3G, 4G or 5G modem 102, and their associatedinformation, including machine or modem serial numbers. The connectivityserver 118 can also be used to receive and provide firmware upgrades,approved by a director of service personnel 134 and obtained remotelyvia service portal 130, to authorized home therapy machines 100 andtheir associated water treatment devices 10.

In one embodiment, a connectivity agent 114 a (not illustrated) may alsobe installed on the water treatment device 10 in addition to beinginstalled on the home therapy machine 100. If the home therapy machine100 cannot communicate with the system hub 120, and system hub 120 needsto communicate with the water treatment device 10, the water treatmentdevice 10 may then directly communicate with the system hub 120 via theconnectivity agent 114 a. Alternatively, connectivity agent 114 a may beinstalled on a separate device or unit (not illustrated), which can beselectively connected to the water treatment device 10, so that watertreatment device 10 can be converted so as to communicate directly withthe system hub 120 again, for example, if home therapy machine 100 losescommunication with system hub 120.

Servicing the Water Treatment Device

In one embodiment, home therapy machine 100 may be operated in a servicemode for service personnel to access, diagnose and troubleshoot bothhome therapy machine 100 and water treatment device 10 on site and/orremotely. For example, if water treatment device 10 encounters aproblem, or if a component of same, e.g., a chemical pack, becomesspent, the patient may be able to call a service personnel ortechnician. The patient and/or service person can then place watertreatment device 10 via the home therapy machine 100 into a service modethat allows the service technician to remotely verify device 10 settingsand functionality for various components of the water treatment device10. In one embodiment, system 110 prevents treatment while the servicetechnician is connected to machine 100 to enhance safety. For example,the service person may be able to logon onto device 10 via machine 100while treatment is paused. Alternatively, machine 100 must be in an idlestate, or even powered down, for the service person to be able to accessthe machine 100 and/or device 10. Further alternatively, the machine 100need only be disconnected from the patient for the service person to beable to access the machine 100 and/or device 10.

Once accessed, the service technician can remotely investigate andretrieve the log files stored on the home therapy machine 100 for thewater treatment device 10 to determine a cause of an error occurring onthe water treatment device 10. The service person may also be able totoggle valves and actuate a pump, for example, to see if a relatedsensor, e.g., pressure sensor, of the water treatment device 10 isoperating properly and/or if a valve or pump of the water treatmentdevice 10 is operating properly. The service person does so by sending acommand to home therapy machine 100. Home therapy machine 100 recognizesthat the command is for water treatment device 10 and passes along thecommand to the processing and memory of the water treatment device 10,which in turn causes the appropriate action to occur on water treatmentdevice 10. Water treatment device 10 sends response data back to hometherapy machine 100, which relays the information back to theappropriate service person.

Requests sent from the service person can either be structured so thatmachine 100 inherently knows whether the request is for home therapymachine 100 or water treatment device 10. Alternatively, the request canbe tagged. For example, the valves for home therapy machine 100 may benumbered consecutively starting from the number one, while the valvesfor water treatment device 10 may be numbered consecutively startingfrom the number one-hundred (assuming home therapy machine 100 has lessthan one-hundred valves). Here, it is inherently known to pass a requestto toggle valve one-hundred-eleven along to water treatment device 10.Alternatively, the valves for both home therapy machine 100 and watertreatment device 10 may be numbered consecutively starting from thenumber one, but wherein the requests are coded, e.g., “A” for hometherapy machine 100 and “B” for water treatment device 10. Here, ACPU112 of home therapy machine 100 knows to keep a request to toggle valveAV4 and to pass along a request to toggle valve BV4 to water treatmentdevice 10.

Control Via One User Interface

In one embodiment, the control processor (ACPU 112) and user interface122 of home therapy machine 100 walk the patient through the entiretreatment process and instruct, on a step-by-step basis, as to howtreatment should be initiated and performed, including instructions foroperating water treatment device 10. In one embodiment, the userinterface 122 is a tablet that runs a custom, secure interface that onlyallows access to the home therapy machine 100. In one implementation,tablet 122 operates wirelessly. Tablet 122 here can plug into hometherapy machine 100 initially for pairing the tablet 122 with the hometherapy machine 100 and for performing software (e.g., firmware)upgrades for the tablet 122. Tablet 122 may also plug into home therapymachine 100 to power or charge the tablet 122. Connectivity betweentablet 122 and home therapy machine 100 may be via a serial dataconnection, over a universal serial bus (“USB”) connection, parallelconnection or via another suitable data transfer interface. Once thetablet 122 is paired to the home therapy machine 100, the tablet 122communicates wirelessly (e.g., using Bluetooth™ or WiFi™) with the hometherapy machine 100.

User interface 122 can alternatively be connected to or tethered tomachine 100, for example, as shown and described in U.S. PatentPublication No. 2009/0114582, the entire contents of which areincorporated herein by reference and relied upon. A connected ortethered arrangement for user interface 122 is accordingly discussedbelow, as illustrated in FIG. 3.

In one embodiment, the user can send data to and receive data frommachine 100 via tablet 122. Data entered into the user interface 122 issecurely sent to the home therapy machine 100 and processed in ACPU 112,which controls machine 100 or forwards commands to be processed by watertreatment device 10, which in turn controls some operation of the watertreatment device 10. In one embodiment, no treatment data is stored intablet 122. Storing no treatment data in the tablet 122 is advantageousbecause if the tablet 122 is disconnected or lost, no sensitive orimportant data is lost.

Because user interface 122 of home therapy machine 100 is also used toenter and display data related to water treatment device 10, watertreatment device 10 does not need and in one embodiment does not provideanything more than a simple display, which may be provided with a fewelectromechanical buttons, such as membrane switches, and an on/offswitch. The simple display may be a small liquid crystal display (“LCD”)or light emitting diode (“LED”) display, which provides a single line orfew lines of text. The electromechanical buttons allow for emergencycontrol of water treatment device 10 in case tablet 122 is lost orcommunication between home therapy machine 100 and water treatmentdevice 10 is broken. The electromechanical buttons alternatively oradditionally allow installation or service of the water treatment device10 in the absence of the home therapy machine 100. The electromechanicalbuttons may also allow a service person to enter a service mode directlyfrom the small keypad, e.g., by pressing and holding a hidden button fora certain number of seconds.

In one embodiment, the user may power and depower home therapy machine100 and/or water treatment device 10 from common user interface 122. Auser may send a command to water treatment device 10 from common userinterface 122. The command may for example request that water treatmentdevice 10 provide an estimate of how much time exists before aconsumable component of water treatment device 10 needs replacement. Forexample, water treatment device 10 may include a carbon filter, asediment removal cartridge, softening filter, reverse osmosis (“RO”)membrane or metallic catalyst filter, which each needs to be replacedafter a certain number of hours of use. Like before, the command fromtablet 122 may be inherent to water treatment device 10, so that ACPU112 has no choice but to forward the command to water treatment device10. Or, the command may be provided with a code that ACPU 112recognizes, upon which ACPU 112 responsively forwards the command towater treatment device 10.

One goal of the present disclosure is to prevent the user from having tolook at two different user interfaces when performing the home therapytreatment under system 110. Besides allowing user interface 122 to be acommon user interface, it is contemplated to make water treatment device10 require as little user interaction as possible. For example, watertreatment device 10 can be configured such that it remains poweredindefinitely with no ill affect to the water treatment device 10. Or,home therapy machine 100 and water treatment device 10 can be configuredsuch that water treatment device 10 receives power whenever home therapymachine 100 is powered. In a similar manner, many commands to hometherapy machine 100 may carry over or have an automatic secondary affecton water treatment device 10. For example, a PAUSE or STOP input fromuser interface 122 to home therapy machine 100 may likewise cause hometherapy machine 100 to automatically issue a PAUSE or STOP command towater treatment device 10. In another example, if home therapy machine100 enters an alarm state while receiving purified water from watertreatment device 10, home therapy machine 100 can cease pumping waterfrom water treatment machine 10.

Operating parameters for home therapy machine 100 may also dictateoperating parameters for water treatment device 10. For example, in thehemodialysis realm, dialysis fluid or dialysate flowrate entered as anoperating parameter into home therapy machine 100 can dictate theflowrate at which water treatment device 10 is commanded to producepurified water, which is used to make the dialysis fluid or dialysate.This leader/follower operating parameter arrangement can be carried outin a plurality of different ways. In one way, ACPU 112 of home therapymachine 100 calculates or finds via a look-up table the operatingparameter for water treatment device 10 based on the correspondingoperating parameter for home therapy machine 100. For example, ACPU 112may store that purified water flowrate is to be set to 1.2 times thedialysate flowrate. ACPU 112 calculates and adjusts on the fly apurified water flowrate knowing the current actual or currentlycommanded flowrate of dialysate for home therapy machine 100. In oneembodiment, ACPU 112 may adjust the purified water flowrate if ACPU 112determines that the patient needs a bolus of fresh solution. Onesuitable method for providing the patient with a bolus of fresh solutionis set forth in U.S. Patent Publication No. 2009/0124963, entitled,“Balanced Flow Dialysis Machine”, filed Nov. 9, 2007, the entirecontents of which are incorporated herein by reference and relied upon.

In a second way, the control processor of water treatment device 10calculates or finds via a look-up table the operating parameter forwater treatment device 10 based upon the corresponding operatingparameter for home therapy machine 100 sent by the home therapy machine100 to the water treatment device 10. For example, the control processorof water treatment device 10 may store that purified water flowrate isto be set to 1.2 times the dialysate flowrate. ACPU 112 sends currentdialysate flowrate periodically to water treatment device 10, which inturn calculates and adjusts on the fly a purified water flowrate knowingthe current actual or currently commanded flowrate of dialysate for hometherapy machine 100.

In a third way, the control processor of water treatment device 10 runsoff of a prescription just like home therapy machine 100. Discussedbelow is a process by which home therapy machine 100 receives one ormore machine operating prescriptions from a doctor or clinician remotelyvia the server 118 and system hub 120 discussed above. When a machineoperating prescription is installed onto ACPU 112 of home therapymachine 100, the prescription comes with a set of instructions orsecondary prescription that is forwarded from ACPU 112 to the controlprocessor of water treatment device 10. When that prescription for thehome therapy machine 100 is then recalled by the user for treatment viahome therapy machine 100, the corresponding set of instructions orsecondary prescription is recalled for use with water treatment device10. In this third way, updating data during treatment between hometherapy machine 100 and water treatment device 10 can be reduced oreliminated.

A fourth way works on a batch or volume basis. Home therapy machine 100can include a dialysate holding tank. ACPU 112 can be configured to makedialysate when tank volume falls to a certain level and stop makingdialysate when tank volume rises to a certain level. Here, watertreatment device 10 is tasked with providing enough water to raise thelow dialysate tank volume to the high dialysate tank volume as opposedto being concerned with dialysate flowrate to the dialyzer. When tankvolume hits the low level, ACPU 112 activates water treatment device 10and the dialysate mixing pumps of home therapy machine 100 to producedialysate and attempt to fill the dialysate holding tank. Watertreatment device 10 and the dialysate mixing pumps remain activateduntil the designated high tank volume is reached. It is contemplated tomaintain different dialysate production rates for water treatment device10 and the dialysate mixing pumps, so that if the water treatment device10 and the dialysate mixing pumps cannot meet demand at a lower rate ofproduction, they can be raised to a higher rate of dialysate production.As ACPU 112 raises or lowers the dialysate production rate, the watertreatment device 10 and the dialysate mixing pumps are both adjustedaccorsdingly.

While dialysate flowrate/purified water flowrate and/or volume controlhas been used to illustrate the leader/follower operating parameterarrangements, it is expressly contemplated to use the arrangements withother parameters, such as parameters relating to the pressure,temperature and/or purity level of the water exiting water treatmentdevice 10.

Referring now to FIG. 2, an example dialysis machine 100 a includes awater purification unit 10 a, a dialysate preparation unit 224, adialysate delivery unit 230 and a disinfection unit 226. Controller 232in one embodiment includes a plurality of controllers, each includingprocessing and memory. Controller 232 can for example include a masteror supervisory processor that controls a plurality of delegateprocessors, each of which are dedicated to various functions related todialysis machine 100 a. Controller 232 can also include redundantprocessing, such as a safety processor which ensures that each of theother processors is performing its function correctly.

Controller 232 can control any one or more of water purification unit 10a, dialysate preparation unit 224 and disinfection unit 226 in additionto controlling heater 234, pumps 236, valves 238 and sensors 240. Hometherapy machine and water treatment device are shown as being separatein FIG. 1A, but they may be in the same housing as shown in FIG. 2. Inone embodiment, the same user interface 122 may be used to control thecontroller 232, which may control any one or more of the various units,e.g., home therapy machine as well as water treatment device. Thedialysis machine 100 a may be powered by branch power 212 and/orsupplemental power supply 214.

Data Connection

Referring now to FIG. 3, FIG. 3 illustrates a subsystem 50 of system 110between water treatment device 10 and home therapy machine 100. Forreference, the simple display and electromechanical buttons discussedpreviously for water treatment device 10 are illustrated by display 20and electromechanical buttons 22. Alternatively, water treatment device10 only includes display 20 and provides only rudimentary input devices.The display on the water treatment device 10 may augment the userinterface 122. The control processing and memory for water treatmentdevice 10 is illustrated by processing and memory 24. Also, as mentionedabove, user interface 122 of home therapy machine 100 is illustrated asbeing tethered or connected to the home therapy machine 100. Userinterface 122 is alternatively an untethered tablet as has beendescribed herein.

As illustrated in FIG. 3, a data communication link 32, e.g., Ethernetor wired communication, is provided to transmit data between processingand memory 24 of water treatment device 10 and ACPU 112 of home therapymachine 100. In one example, water treatment device 10 uses link 32 tosend to the home therapy machine 100 state or status information,component life information, sensor levels or readouts, self testresults, alert and alarm information and hardware and/or softwareversion information. The water treatment device 10 can also indicateinformation about the water flow between the water treatment device 10and the home therapy machine 100 including flowrate information, watertemperature information and line connection disinfection information.

As further illustrated in FIG. 3, data communication link 32 may also beused to transmit data between ACPU 112 of home therapy machine 100 andprocessing and memory 24 of water treatment device 10. As discussedabove, or in addition to above, home therapy machine 100 can send to thewater treatment device 10 data regarding state change requests, commands(e.g., RUN, PAUSE or STOP), status queries, flowrate change requests,software upgrades or downgrades, and/or file, e.g., device prescription,transfers.

As discussed herein, user interface 122 indicates information about thewater treatment device 10 to user 12. For example, the user interface122 may display to user 12 information such as an alarm or an alertnotice, water treatment device performance information, trouble shootinghelp, task guidance and/or action requests. For example, user 12 viauser interface 122 can ask water treatment device 10 to identify itselfto ensure data connection 32 between machine 100 and device 10 isfunctioning properly and to verify compatibility, such as hardwareversion and software version compatibility, between device 10 andmachine 100. If so, device 10 can itself make an audible beep or answerand/or send a confirming message back to user interface 122, e.g., “I amhere”. The user 12 can then take appropriate action, either via userinterface 122 or by performing some task indicated by the user interface122. To do so, user 12 need only interact with common user interface122. In this way, user 12 can have minimal interaction with watertreatment device 10, such as to perform a hard power-on and off, makephysical data and power connections, perform filter changes and/or takemanual measurements, while ensuring that water treatment device 10 isfunctioning properly and in communication with machine 100.

In addition to the data connection 32 between home therapy machine 100and water treatment device 10, there is a water feed line 34 runningfrom water treatment device 10 to home therapy machine 100. Water feedline 34 sends water at a specified level of sterility, flowrate,pressure and/or temperature to home therapy machine 100. Water sent fromthe water treatment device 10 to the home therapy machine 100 ismaintained typically at between about 5° C. and 35° C. Line 34 may inone embodiment be used to return unused water product from home therapymachine 100 to water treatment device 10.

In one embodiment, processing and memory 24 of water treatment device 10operate as a slave or delegate processor to the programmed ACPU 112 ofhome therapy machine 100. The water treatment device 10 can inform thehome therapy machine 100 of its status, such as an alarm situation, andsend any other pertinent data to ACPU 112. Home therapy machine 100stores and acts upon the data, e.g., decides whether to raise an alarm.Home therapy machine 100 thus controls the behavior of water treatmentdevice 10.

Water treatment device 10 may be in any one of several different states,such as “Installation”, “System Rinse”, “Hibernate” or “Therapy”. Hometherapy machine 100 is responsible in one embodiment for requesting thatwater treatment device 10 changes states, e.g., from “Hibernate” to“Therapy”. In “Hibernate”, water treatment device 10 is maintained in aminimum power usage state. In “Therapy”, water treatment device 10 isbrought to a fully capable power level. As discussed above, the presentsystem and method contemplate many ways of pairing water treatmentdevice 10 to home therapy machine 100 upon a request for water by thehome therapy machine 100. In each alternative, water treatment device 10provides water suitable for treatment, and in a suitable quantity orflowrate, to home therapy machine 100.

Water treatment device 10 may send information to be displayed on theuser interface 122 to prompt necessary user actions. Water treatmentdevice 10 may send status information to the home therapy machine 100asynchronously or in response to a status query. The water treatmentdevice 10 may also send error packets to the home therapy machine 100 incase of an error or an alarm. The home therapy machine 100 can decidewhat actions need to be taken and whether the user 12 should be notifiedvia user interface 122. If the user 12 needs to provide any input forclearing the alarm, the user 12 can do so via user interface 122. Watertreatment device 10 is responsible for notifying home therapy machine100 about its current state. Water treatment device 10 is alsoresponsible for notifying home therapy machine 100 about any alarms oralerts.

When water is required for therapy, home therapy machine 100 in oneembodiment discussed above specifies to the water treatment device 10the desired flowrate of the water. The water treatment device 10 thenprovides water at the desired flowrate. Or, as discussed above, watertreatment device 10 calculates or looks up its flowrate based upon atherapy fluid flowrate sent from home therapy machine 100. Or, asdiscussed above, water treatment device 10 determines its flowrate fromits own device prescription. Still further as provided above, watertreatment device 10 and home therapy machine 100 can instead cooperateon a volumetric basis.

It should be appreciated that using and controlling both water treatmentdevice 10 and home therapy machine 100 from the user interface 122increases safety, minimizes the complexity of operating multiple devicesand reduces the burden of therapy on patients at home. The functioningof water treatment device 10 and the home therapy machine 100 is alsostreamlined via the master/delegate processor arrangement.

Installing Water Treatment Device

It is contemplated under system 110 for water treatment device 10 andhome therapy machine 100 to work together in many different ways,facilitated in many instances by common user interface 122. Referringnow to FIG. 4, for example, process 400 illustrates an example processfor installing or initially setting up water treatment device 10 usinguser interface 122 of home therapy machine 100. Upon starting process400 at the start oval, a user 12 connects water treatment device 10 tothe home therapy machine 100 as shown at block 402, e.g., makes dataconnection 32 and water line connection 34 discussed above. Userinterface 122 upon sensing the data connection prompts the user 12whether the user would like to be guided through installation of thewater treatment device 10, as shown at block 404. If the user 12 selects“No”, process ends at the end oval near block 404. If the user 12selects “Yes”, user interface 122 prompts the user 12 to first installan RO cartridge and press “Confirm” on user interface 122, as shown atblock 406.

When the user 12 presses “Confirm”, home therapy machine 100 querieswater treatment device 10 as to whether the RO cartridge is detected andcorrectly installed, as shown at block 408. If the RO cartridge is notdetected or not correctly installed, water treatment device 10 reportsan error condition as shown at block 410, and displays an error messageon user interface 122, as shown at block 411. If the RO cartridge isdetected and correctly installed, water treatment device 10 responds atuser interface 122 that the RO cartridge is present and providescartridge information to the home therapy machine 100, as shown at block412.

Next, user interface 122 displays to the user 12, “Now install thepretreatment cartridge and press Confirm”, as shown at block 414. Whenthe user 12 installs the cartridge and presses “Confirm” at userinterface 122, home therapy machine 100 queries the water treatmentdevice 10 as to whether the pretreatment cartridge is present, as shownat block 416. If the pretreatment cartridge is not present or there isan error, the water treatment device 10 responds with a pretreatmentcartridge error, as shown at block 418, in which case the user interface122 displays a message to the user 12 that the pretreatment cartridge isnot installed properly, as shown at block 420. If the pretreatmentcartridge is present, the water treatment device 10 responds that thepretreatment cartridge is present and provides cartridge information tothe home therapy machine 100, as shown at block 422.

Next, user interface 122 displays a message to the user 12 to connectthe water treatment device 10 to feed water, turn on the feed water andpress “Confirm”, as shown at block 424. When the user 12 presses“Confirm”, home therapy machine 100 queries water treatment device 10 asto whether the feed water has been connected and/or whether the feedwater pressure is acceptable, as shown at block 426.

Next, user interface 122 prompts the user 12 to, “Place the drain lineinto the drain, and ensure that an air gap is present”, as shown atblock 428. Once the user 12 confirms these steps, user interface 122displays a message to the user 12 that the water treatment device 10will begin rinsing and that rinsing may take several hours, as shown atblock 430. The user interface 122 also displays a “Rinse” button. Oncethe user 12 presses the displayed “Rinse” button, water treatment device10 begins rinsing, as shown at block 432. A separate “Rinse” buttonaccordingly need not be provided on water treatment device 10, althoughone may be provided for redundancy. In any case, water treatment device10 changes its state to “Rinsing” and informs home therapy machine 100of this change in state, as shown at block 434. User interface 122displays, “Rinsing. Press Stop to Pause Rinse process”, and displays a“Stop” or “Pause” button accordingly, as shown at block 436. Watertreatment device 10 may also report the state of its valves and pumps inaddition to its overall system mode, as shown at block 438. When therinsing is complete, user interface 122 displays that rinsing has beencompleted, as shown at block 440. A change of state is also reported tohome therapy machine 100, as shown at block 442. Process 400 then endsas illustrated at the end oval.

It should be appreciated that while the steps of process 400 involvespecific functions to be performed on water treatment device 10, thedisplay of instructions and user inputs for same occur on the userinterface 122. Thus, the user 12 can focus solely on user interface 122to install the water treatment device 10 and to run treatment on hometherapy machine 100.

Making Water

FIG. 5 illustrates an example process 500 for making water with watertreatment device 10 using user interface 122 of home therapy machine100. Upon starting process 500 at the start oval, home therapy machine100 instructs water treatment device 10 to become active or “wake up”and produce water at a specified flowrate (or until a specified volumeof dialysate is reached in the dialysate holding tank), as shown atblock 502. In one embodiment, the water treatment device 10 performsnecessary functions prior to producing water. Upon becoming active orwaking up, home therapy machine 100 performs startup activities, such asself-tests, rinsing, and safety checks. When water treatment device 10has completed the activities required, the device “wakes-up” and isready to produce water, as shown at block 506. Home therapy machine 100continuously queries water treatment device 10′s status and displayssuch status on user interface 122, as shown at block 508. When watertreatment device 10 is finished waking up and is ready to producepurified water, if home therapy machine 100 is occupied, as shown atblock 510, water treatment device 10 waits for the home therapy machine100 to draw water, as shown at block 512. Once home therapy machine 100is ready, home therapy machine 100 begins to draw water, as shown atblock 514. User interface 122 displays to the user 12 that the hometherapy machine 100 is drawing water from water treatment device 10, asshown at block 516.

User interface 122 may also provide an option for the user 12 to changethe water preparation flowrate of water treatment device 10 or to pauseor stop production of same. Or as discussed above, home therapy machine100 may instruct water treatment device 10 to change the flowrate basedupon instructions stored in the ACPU 112. Water treatment device 10 inone embodiment is configured to change its recovery ratio based ondemand. The RO units of water treatment device 10 produce reject water.The reject water can be reclaimed and fed back into the RO units,reducing water actually rejected to drain, but doing so can reduce theservice life of the RO units because feeding the RO units with recycledreject water can cause fouling to occur. However, in the event that hometherapy machine 100 is not using all of the available stream of purifiedwater produced by water treatment device 10, the rejected water streamfrom the RO units can be mixed with the excess purified water, creatinga solution that is functionally equivalent to tap water, and which willnot cause excessive fouling of the RO units. In this way, the watertreatment device 10 can adjust the amount of rejected RO water to berecycled based upon the availability of unused purified water that canbe mixed with the reject stream prior to reentering the RO units.

When home therapy machine 100 is finished drawing water, home therapymachine 100 instructs water treatment device 10 to hibernate, as shownat block 518. In hibernate, water treatment device 10 continues tocommunicate with home therapy machine 100 to wait for an eventualcommand to wake-up again. Also, in hibernate water treatment device 10may periodically perform rinses of its flow path after set periods ofstagnation to maintain its performance in the absence of a command towake-up. Water treatment device 10 changes its state to hibernate andconveys its state to the home therapy machine 100 for display to user12, as shown at block 520. Process 500 then ends as illustrated at theend oval.

Starting Up Home Therapy Machine and Water Treatment Device

FIG. 6 illustrates an example process 600 for starting up home therapymachine 100 and water treatment device 10 using user interface 122 ofhome therapy machine 100. Upon starting process 600 at the start oval,user interface 122 walks the user 12 through start-up tests related towater treatment device 10, as shown at block 602. For example, userinterface 122 can ask the user 12 to check and run self tests for the UVlight intensity, RO rejection percentage and total organic carbon(“TOC”) level, each associated with water treatment device 10. Otherself tests associated with water treatment device 10 include, forexample, whether or not remaining pretreatment cartridge life issufficient.

The water treatment device 10 self tests may include achlorine/chloramines test. For example, the ACPU 112 may decide that achlorine/chloramines test should be run. The user interface 122 mayprompt the user to collect a water sample from water treatment device 10for testing, optionally by pressing a button on user interface 122. Achlorine/chloramines test is performed, as shown at block 603, and theuser interface 122 displays to the user chlorine/chloramines test resultoptions (e.g. Pass or Fail) and may prompt the user for a response, asshown at block 606. Depending upon the result of thechlorine/chloramines test, process 600 may either complete other selftesting for device 10, return to home therapy machine 100 self testingor proceed with a different task for the water treatment device 10.

Process 600 may accordingly interleave between steps 602 and 603 asshown by the dual direction arrows between steps 602 and 603. Forexample, if the water treatment device 10 does not pass thechlorine/chloramines test, home therapy machine 100 may signal to thewater treatment device 10 that a pretreatment swap is required or thatthe sample needs to be retested to confirm a failure. The watertreatment device 10 changes its system state to “Cartridge Swap” andconfirms the state change to ACPU 112. User interface 122 displays touser 12 that water treatment device 10 requires a pretreatment cartridgeswap. The user interface 122 then walks user 12 through the steps forswapping the pretreatment cartridge. Any errors from the water treatmentdevice 10 are displayed to the user 12 via user interface 122, or userinterface 122 may prompt the user for a response, as shown at block 606.Upon completion of the steps for the pretreatment cartridge swap, thewater treatment device 10 changes its state and conveys its state to thehome therapy machine 100 for display to user 12.

If all the self tests associated with water treatment device 10 havepositive results with no errors, user interface 122 transitions torunning self tests for home therapy machine 100, as shown at block 604.Or, ACPU 112 may alternate self tests between home therapy machine 100and water treatment device 10. In other words, it may not be desirableto run all of the home therapy machine 100 self tests first and then runthe water treatment device 10 self tests, or vice versa, as discussedabove. The self tests may be interleaved or run simultaneously. Process600 may accordingly interleave between steps 602, 603 and 604 as shownby the dual direction arrows between steps 602 and 603 and 602 and 604.At any time, the self test for either home therapy machine 100 or watertreatment device 10 may display a result to or prompt user 12 for aresponse on user interface 122, as shown at block 606. Such interleavingof testing increases efficiency and saves time, while enabling the user12 to pay attention to a single user interface 122.

Process 600 ends as illustrated at the end oval, and may end from anyone of steps 602, 603 or 604, depending upon the results of the selftests and the order of interleaving between the self tests.

Performing Pre-treatment Cartridge/Membrane Swap

FIG. 7 illustrates an example process 700 for performing a pre-treatmentcartridge swap in water treatment device 10 using user interface 112 ofthe home therapy machine 100. Upon starting process 700 at the startoval, water treatment device 10 checks whether the pre-treatmentcartridge has completely degraded, as shown at block 702. If thepre-treatment cartridge has not completely degraded, but needs to bechanged soon, the water treatment device 10 transmits an alarm over dataconnection 32 to the home therapy machine 100, as shown at block 704.User interface 122 displays that the pre-treatment cartridge should bechanged soon and presents options and selection buttons to user 12 as towhether the user 12 wishes to change the pre-treatment cartridge now orlater in one embodiment, as also shown at block 706. If the userselects, via user interface 122, to change the pre-treatment cartridgelater, process 700 ends as illustrated at the end oval. If the userselects, via user interface 122, to change the pre-treatment cartridgenow, process 700 proceeds to step 712, described below.

If the pre-treatment cartridge has completely degraded and needs to bechanged immediately before water treatment device 10 can make water,water treatment device 10 transmits an alarm over data connection 32 tothe home therapy machine 100, as shown at block 708, which causes userinterface 122 to display to the user 12 that the pre-treatment cartridgemust be changed immediately, as shown at block 710.

If the user 12 elects at user interface 122 to change the pre-treatmentcartridge now (in the case in which the pre-treatment cartridge is notnecessary), or the pre-treatment cartridge must be changed immediately,the user interface 122 in one embodiment walks user 12 through theprocess of changing the pre-treatment cartridge, as shown at block 712.Instructions for user tasks are displayed on the user interface 122.Once the pre-treatment cartridge swap is complete, water treatmentdevice 10 changes its state, as shown at block 714, which is displayedto the user 12 via user interface 122, as shown at block 716. In variousembodiments, process 700 may be used alternatively or additionally toperform an RO membrane swap. Process 700 then ends as illustrated at theend oval.

Setting Up and Using Supplies and Therapy Prescription

Medical products and drugs are shipped or delivered to a patient's homefor the home therapy machine 100 to use during treatment. Typically,only therapy products or drugs approved under a doctor's prescriptioncan be shipped to the patient's home. In the U.S., such prescriptionstypically last one year, and patients may have more than oneprescription available to them at any given time in order to dynamicallymanage their condition. One or more prescription is stored for eachpatient in the system hub 120. Each home therapy machine 100 usessupplies and settings according to the prescription. If the patient'sprescription changes or if a prescription is added, the patient'sclinician uses web portal 150 to update the settings of home therapymachine 100 to change or add the prescription. If the home therapymachine 100 settings are updated, system hub 120 sends the updatedsettings to home therapy machine 100 via the connectivity service asdiscussed previously, e.g., in one embodiment, the home therapy machine100 only communicates with system hub 120 when connectivity agent 114 isturned on.

Referring now to FIG. 8, process 800 illustrates an example process forshipping inventory and programming a prescription for home therapymachine 100 based upon a doctor's prescription for a particular patient.That is, a doctor associated with the clinic 152 a to 152 n can alsoaccess system hub 120 via web portal 150 to deliver a therapyprescription for the patient (used for both supplies and machineoperation) to the clinician. Upon starting process 800 at the startoval, the clinician retrieves an electronic prescription prescribed by adoctor using the web portal 150 as shown at block 802. At the web portal150, the clinician selects the dialyzer, blood tubing set, acid,bicarbonate, needles, etc. and any other supplies, including possiblysupplies for water treatment device 10, necessary to fulfill theprescription to run on home therapy machine 100. The selected dialyzerand other supplies will be shipped to the patient's home as shown atblock 804.

At the same or different time, the clinician may remotely access thesystem hub 120 through the web portal 150 to program a prescription forhome therapy machine 100, as shown at block 806. The system hub 120holds the therapy prescription in one embodiment until the connectivityagent 114 on a home therapy machine 100 is turned on, as shown at blocks820 to 824.

The clinician sets various treatment parameters used to program aprescription for the home therapy machine 100 as shown at block 808,such as blood flowrate, dialysate flowrate, UF volume and heparinflowrate flush. In one embodiment, the settings specified by theclinician include settings for operating the water treatment device 10or may affect the parameters for water treatment device 10, as explainedabove, so separately setting parameters for water treatment device 10 isnot necessary. Or, the clinician may separately set various treatmentparameters used to program a prescription for the water treatment device10, as shown at block 810.

The clinician also specifies allowed ranges for the various settings asshown at block 812. That is, the patient may be allowed to pick within arange of values for certain parameters under the specified therapyprescription. In this manner, the patient has a certain amount ofcontrol over the treatment that is performed. Dialysate temperature, forexample, may be set within a range of allowable values based uponpatient preference and comfort. The clinician further specifies whetheror not the patient will have the ability to modify the settings at allas shown at block 814. If the patient is allowed to modify parametersettings, the setting variability is within an allowed range, such thatthe patient picks a value inside the range specified by the clinician atblock 812. The clinician then submits the settings to the system hub 120as shown at block 816.

The system hub 120 then sends the therapy prescription to theconnectivity server 118 as shown at block 818. When the connectivityagent 114 residing at home therapy machine 100 is next turned on orenabled as shown at block 820, home therapy machine 100 checks theconnectivity server 118 for a therapy prescription as shown at block822. If a therapy prescription is present at the connectivity server 118for the home therapy machine 100, connectivity server 118 sends thetherapy prescription to the home therapy machine 100 as shown at block824. Machine 100 prompts the patient to accept the therapy prescription.In one embodiment, the patient must accept the therapy prescription tocontinue using the home therapy machine 100, as shown at block 826.

In one embodiment, the therapy prescription downloaded from theconnectivity server 118 may be a new or updated prescription, meant toreplace a previous therapy prescription already on the machine 100.Before treatment begins, e.g., after disinfection the day before, ACPU112 of home therapy machine 100 checks whether the connectivity servicevia agent 114 has posted an updated therapy prescription for thatparticular home therapy machine 100. To do so, in one embodiment, thehome therapy machine 100 and the system hub 120, through theconnectivity service, compare prescription version numbers to determinewhether home therapy machine 100 has the most updated prescription. Ifnot, the most recent prescription version is delivered to therapymachine 100. Machine 100 will not run an old therapy prescription if anew therapy prescription has been downloaded from connectivity server118 and is present on machine 100. However, the new therapy prescriptionwill not overwrite the old therapy prescription until the patientaccepts the therapy prescription as shown at block 826. In this manner,the patient confirms that the patient knows that his or her treatmenthas changed. Upon accepting the new therapy prescription, the newtherapy prescription is written into the memory of therapy machine 100.In an alternative embodiment, machine 100 can store multiple therapyprescriptions in memory so even when a new therapy prescription isdownloaded, the old therapy prescription is kept in memory. Machine 100may be able to store different types or categories of therapyprescriptions. Each different type of therapy prescription may provide adifferent treatment, e.g., to remove a low amount, medium amount, orlarge amount of ultrafiltration for dialysis. The machine 100 may beable to store one therapy prescription in each category.

ACPU 112 receives the settings and separates the home therapy machine100 settings from the water treatment device 10 settings and sends thewater treatment device 10 settings over the data connection 32 to thewater treatment device 10, as shown at block 827. The settings may beflagged as being intended for the home therapy machine or the watertreatment device 10. Or, the ACPU 112 may recognize characteristics inthe settings as inherent to the water treatment device 10 and pass thosesettings to the water treatment device 10. The next time the patient isabout to perform treatment, the connectivity agent 114 is turned off asshown at block 828. The home therapy machine 100 as shown at block 830now runs a treatment using the therapy prescription specified at blocks808 and/or 810. Home therapy machine 100 writes treatment data producedby the treatment to the log files as shown at block 832. Again, the logfiles document pertinent home therapy machine 100 data and pertinentwater treatment device 10 data over the course of the treatment. In oneembodiment, the water treatment device 10 sends its own log files to thehome therapy machine 100. The home therapy machine 100 appends the datafrom the water treatment device 10 to the log files of the home therapymachine 100. The next time connectivity agent 114 is turned on, thecombined log files stored in the home therapy machine 100 are sent toconnectivity server 118.

Connectivity agent 114 is turned on as shown at block 834. In oneembodiment, the home therapy machine 100 initiates the connection to theconnectivity service. In an alternative embodiment, the connectivityservice may initiate the connection to the home therapy machine 100. Atblock 836, the log files are uploaded to connectivity server 118.Process 800 then ends as illustrated at the end oval.

In one embodiment, machine 100 can perform post treatment procedures,such as a disinfection procedure that cleans the machine and thedisposables used for treatment for the next treatment. In oneembodiment, system 110 allows the connectivity agent to be turned on atblock 834 after treatment but while post-treatment disinfection is takenplace. Writing treatment data at block 832 can also be done duringdisinfection. Alternatively, the home therapy machine 100 waits to writedata at block 832 or turn on the connectivity agent at block 834 untildisinfection is completed and the machine 100 enters an idle mode.

In the illustrated embodiment, because the connectivity agent 114 turnsoff before treatment and does not turn on again until after treatment,system 110 provides no real-time monitoring of a treatment. Events thatoccur during a treatment, including alarms and alerts, are not reportedto the system hub 120 immediately. Such information is part of the logfiles that are sent to the system hub 120 after treatment. In analternative embodiment, the connectivity agent 114 may remain on duringtreatment and may report information about the home therapy machine 100and the treatment in real-time.

Firmware Upgrades

From time to time, the software that ACPU 112 runs on home therapymachine 100 and/or the software that runs on processing and memory 24 onwater treatment device 10, which may also be referred to herein asfirmware, may need to be upgraded. The home medical device system 110provides an efficient and reliable manner for upgrading firmware thatintegrates the product development team 128 and service personnel 132 ato 132 n (FIG. 1A).

FIG. 9 illustrates an example process 900 for upgrading firmware on thehome therapy machine 100. Upon starting process 900 at the start oval, aproduct development team 128 develops a firmware upgrade for hometherapy machine or water treatment device 10, as shown at block 902. Atblock 904, the product development team 128 uploads the firmware upgradeto the system hub 120. The service portal 130 then allows a servicepersonnel director or decision-maker 134 to view and approve theupgrade. Upon approving the upgrade, director 134 uploads the upgradefrom system hub 120 to the connectivity server 118, as shown at block906. In the illustrated embodiment of FIG. 1A, director 134 is separatefrom the service personnel 132 a to 132 n that are responsible forservicing and maintaining home therapy machines 100 and water treatmentdevices 10, and for maintaining relationships with the patients. Servicepersonnel director 134 not only has the authority to finalize whetherthe upgrade is sent to the connectivity server 118, director 134 canalso designate which machines 100 and/or water treatment devices 10receive the upgrade, if not all machines 100 or devices 10, and refusethe upgrade or return it to the product development team 128 forrefinement. Once an upgrade is allowed to reach connectivity server 118,service personnel 132 a to 132 n, or designated ones thereof, can viewthe firmware upgrade through service portal 130 as illustrated at block908. In one embodiment, the product development team 128 uploads thefirmware upgrade directly to the connectivity server 118, without goingthrough the system hub 120.

As discussed above in connection with FIG. 1A, service personnel 132 ato 132 n manage the day-to-day relationship with the patients. Servicepersonnel 132 a to 132 n are familiar with patient schedules and are inthe best position to determine when a patient should receive thefirmware upgrade. For example, service personnel 132 a to 132 n willknow the maintenance and activity schedule for the home therapy machines100 and corresponding water treatment devices 10 that they normallyservice. If the patient's machine 100 and/or water treatment device 10is scheduled to soon receive a part needed for the firmware upgrade,then the service personnel 132 a to 132 n can wait until the new part isinstalled before upgrading the firmware (which may, for example, needthe new part) on the patient's home therapy machine 100 and/or watertreatment device 10.

Each service personnel 132 a to 132 n selects which of its designatedhome therapy machines 100 and/or water treatment devices 10 shouldreceive the firmware upgrade as shown at block 910. The next timeconnectivity agents 114 on the selected home therapy machines 100 areturned on, as shown at block 912, connectivity server 118, waiting forthe agents to be turned on, sends the upgrade to the selected hometherapy machines 100 and/or water treatment devices 10 as shown at block914.

In one embodiment, the selected home therapy machines 100 and/or watertreatment devices 10 may decide, based upon settings stored in the ACPU112 and/or processing and memory 24, whether or not to accept theupgrade, as shown at block 916. If the selected home therapy machines100 and/or water treatment devices 10 selects not to upgrade, process900 ends as shown at block 916 and the end oval. If any of the selectedhome therapy machines 100 and/or water treatment devices 10 accept theupgrade, the corresponding patients are prompted via user interface 112as to whether they would like to install the upgrade, as shown at block918. If the patients, via user interface 112, do not choose to upgradethe selected home therapy machines 100 and/or water treatment devices10, the process 900 ends as shown at block 920 and the end oval. If thepatients, via user interface 112, choose to upgrade the selected hometherapy machines 100 and/or water treatment devices 10, the upgrade(s)are performed, and the home therapy machines 100 inform the patients,via user interface 112 that the software has been upgraded as shown atblock 922. Some countries require by law that patient approval must beobtained before upgrading a patient's firmware. In one embodiment,system 110 may require that only home therapy machines 100 in countriesthat require patient approval prompt patients to accept the firmwareupgrade at blocks 918 and 920.

Home therapy machines 100 may be allowed to retain the ability to revertback to a previous software version for either or both of machine 100 ordevice 10. For example, if a firmware upgrade is corrupt, or if thefirmware on a home therapy machine 100 or water treatment device 10becomes corrupt, home therapy machine 100 in an embodiment is allowed torevert back to a previous, non-corrupt software version. Alternatively,home therapy machine 100 cannot revert back to a previous softwareversion. Here, if the software is or becomes corrupted, new software isinstalled or home therapy machine 100 or water treatment device 10 isswapped with a new home therapy machine 100 or water treatment device10.

The connectivity service at server 118 documents all events related tofirmware upgrades, such as which patients have received upgrades, andwhich service personnel 132 a to 132 n have been involved in theupgrades. The connectivity server 118 stores serial numbers, trackingnumbers and software versions so the various steps in the upgradeprocess are documented and so that at any given moment the currentsoftware version of each machine 100 and device 10 on system 110 can bereadily obtained. At the end oval in FIG. 9, process 900 ends.

As discussed above, any software updates for the water treatment device10 can also be sent to the water treatment device 10 through the hometherapy machine 100. Home therapy machine 100 can receive a combinedsoftware upgrade that contains software upgrades for both the hometherapy machine 100 and the water treatment device 10. Or, the upgradescan be delivered separately. The ACPU 112 then analyzes and separatesthe software contents for the home therapy machine 100 from the softwarecontents for the water treatment device 10. In particular, the ACPU 112can recognize which software contents are intended for the home therapymachine 100 and which software contents are intended for the watertreatment device 10. For example, the software contents may inherentlylook or include content that is particular to either the home therapymachine 100 or the water treatment device 10. Or, the software contentmay be flagged as being for the home therapy machine 100 or the watertreatment device 10. The home therapy machine 100 then sends thesoftware contents for the water treatment device 10 over the dataconnection 32 to the water treatment device 10.

Firmware upgrades may additionally be provided in the manner describedabove for other home components of system 10, e.g., tablet 122, bloodpressure monitor 104 and/or scale 106.

Clinician Dashboard with Rule-Evaluation

A clinician can view a list of the clinician's patients and a file foreach patient showing how treatments for the patients have transpired.The treatment files are derived from the log files in the home therapymachine 100, including flowrates achieved, ultrafiltrate removal,ultrafiltration rates achieved, blood pressure over the course oftherapy, weight, etc. The log files may also include treatment data forwater treatment device 10 as described above. Stored treatment data forwater treatment device 10 can include for example, total purified watervolume delivered, average water temperature, average water pressure,number of delivery requests from machine 100, alerts and alarminformation, chlorine/chloramines levels, and/or component use orreplacement information.

A clinician can sort the list of patients by numerous categories,including the type of treatment they have received, e.g., hemodialysis(sub-categorized as for example short daily, nocturnal, every other day,and every other night), peritoneal dialysis (sub-categorized ascontinuous cycling peritoneal dialysis (“CCPD”), tidal, for example),the supervising doctor, or by the notifications described below. Aclinician can also view a patient snapshot and an overview for the week,month or other duration.

Web portal 150 provides a clinician dashboard having notifications aboutevents that occurred during treatment. In one embodiment, thenotifications include colored flags, with different colors correspondingto different notification conditions. The clinicians can choose whichevents generate the red or yellow flags that appear on the dashboard. Inone embodiment, the flag settings are clinic-specific, notpatient-specific. Thus, choosing to be notified about certain eventsapplies to all patients in the clinic or under the clinician's case. Forexample, a clinician may set a rule that a yellow flag should appear onthe dashboard if a treatment lasted less than four hours. This rulewould then apply to all patients at that clinic or under thatclinician's care. The dashboard will indicate, e.g., with yellow flags,any patients who have undergone a treatment that lasted less than fourhours. The flags may also pertain to water treatment device 10, e.g.,post a flag when a disposable component of water treatment device 10 hasless than ten hours of service left, or post a red flag if testedchlorine/chloramines reaches a certain level.

FIG. 10A illustrates an example dashboard screen 1000 for a clinic on aclinician's display device 192. Dashboard screen 1000 is in oneimplementation the first screen a clinician sees upon logging into theweb portal 150. Dashboard screen 1000 provides an overview ofinformation about the patients handled by that clinic, as well as howthe treatments performed by home therapy machine 100 and water treatmentdevice 10

The patients are listed by name as shown at column 1002. Dashboard 1000may enable the clinician to apply filters as illustrated by drop downmenu 1010. For example, the clinician in the illustrated embodiment canfilter information in the dashboard by patient type (not shown), byphysician at dropdown menu 1012, or by the status of a patient (notshown). The clinician can also filter information in the dashboard toonly show treatments for which there has been no communication usingcheckbox 1014, or to only show treatments for which a flag has beengenerated using checkbox 1016. The filters allow the clinician to honein on particular, desired information.

Various icons 1004, 1006 and 1008 indicate information about a treatmentperformed by that patient on a specific date. Icons 1004, 1006 and 1008may indicate different types of events. For example, icon 1004 may beused to indicate that a treatment performed by the home therapy machine100 and water treatment device 10 has been performed successfully. Icon1006 may be used to notify the clinician about events that are notcritical and do not need immediate action, but need to be closelymonitored in the future. Icon 1008 for example may be used to notify theclinician of events that need immediate action.

A user is able to access a legend using link 1018. When a user selectslink 1018, a popup window or new screen 1050 appears. FIG. 10Billustrates an example legend screen 1050 on a clinician's displaydevice 192 that explains the various icons that can appear on dashboardscreen 1000. Icon 1004 indicates that the treatment performed by hometherapy machine 100 and water treatment device 10 went “Ok.” Icon 1008indicates a high priority flag. Icon 1006 indicates a flag of normalpriority. Icon 1010 indicates that there has been no communication withthe home therapy machine 100 associated with that patient for a specifictreatment.

In one embodiment, the dashboard also displays information collected bythe water treatment device 10 in the water treatment device 10 logfiles. FIG. 11A illustrates an example treatment summary screen 1100,which is part of the clinician dashboard or accessible via a link fromthe dashboard, on a clinician's display device 192. Treatment summaryscreen 1100 provides granulated details about a particular treatmentperformed on a patient by home therapy machine 110 and water treatmentdevice 10 as collected in the log files as described above. FIG. 11Ashows information about a treatment performed by home therapy machine100 and water treatment device 10 on Jul. 31, 2010, as indicated atchart 1102. From treatment summary screen 1100, a clinician can see adescription of the flag symbols at chart 1101. The clinician can alsoview the date, start time and total dialysis time at chart 1102, theprescribed device program at chart 1104 and overall treatment summarylog in table format showing exact times for various treatment events forhome therapy machine 100 and/or water treatment device 10 at chart 1106.The treatment summary screen 1100 also indicates information collectedfrom water treatment device 10. For example, item 1107 in chart 1106indicates to a clinician that water treatment device 10 registered acold water alert at time 20:41:13. Any of the alerts or eventsdocumented in the log files and displayed on the clinician dashboard mayalso have been communicated to the user 12 via user interface 122 duringthe therapy at the time the alert or event occurred.

The screen 1100, displayed on a clinician's display device 192, iscontinued on FIG. 11B. As shown in FIG. 11B, a clinician can view fluidmanagement particulars at chart 1108, information about the treatmentdose at chart 1110, heparin particulars at chart 1112, dialyzer extendeduse data at chart 1114, blood pressure at chart 1116, and pulseparticulars at chart 1118. A clinician can also view information aboutpretreatment samples taken for comparison purposes at chart 1120,including the time 1121 that a water sample was taken from watertreatment device 10. A clinician can also view details about theprescribed device program at chart 1122. The clinician can also view thedevice ID of the home therapy machine 100 and the software versions ofthe home therapy machine 100 as well as the water treatment device 10 atchart 1124.

FIG. 12 illustrates an example patient usage report 1200 that may bepresented to a clinician at web portal 150 on a clinician's displaydevice 192. The example patient usage report 1200 allows a clinician toview the amount of product or consumables utilized by home therapymachine 100 and water treatment device 10 in treating a specific patientover a specified time frame. In the patient usage report 1200, theclinician can view the treatment month 1202 as well as informationrelating to usage by home therapy machine 100, such as the dialyzer used1204, the blood treatment set used 1206, the acid concentrate used 1208and the bicarbonate concentrate used 1210. The clinician can also viewinformation relating to usage by water treatment device 10, such as thewater pre-filters used 1212 and the water distribution loop used 1214.Thus, the clinician can view information about the usage of consumablesover one or several treatments that relate to the home therapy machine100 as well as the water treatment device 10.

Additional Aspects of the Present Disclosure

Aspects of the subject matter described herein may be useful alone or incombination with any one or more of the other aspect described herein.Without limiting the foregoing description, in a first aspect of thepresent disclosure, a home medical device system includes a home therapymachine for performing a home therapy on a patient; a user interfaceoperably connected to the home therapy machine, the user interfacereceiving operator inputs; a water treatment device in fluidcommunication with the home therapy machine; and a data connectionbetween the home therapy machine and the water treatment device, whereinthe home therapy machine transmits data via the connection to the watertreatment device for control of the water treatment device, the dataprovided based on at least one of the operator inputs received via theuser interface.

In accordance with a second aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the water treatment device transmits to the home therapy machine atleast one of: (i) state information, (ii) component life information,(iii) self test results, (iv) alert information or (v) versioninformation.

In accordance with a third aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the user interface displays at least one of: (i) the state information,(ii) the component life information, (iii) the self test results, (iv)the alert information or (v) the version information.

In accordance with a fourth aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the home therapy machine transmits to the water treatment device atleast one of: (i) state change requests, (ii) status queries, (iii)flowrate change requests, (iv) software upgrades or downgrades, or (v)file transfers.

In accordance with a fifth aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,wherein the user interface displays at least one of: (i) the statechange requests, (ii) the status queries, (iii) the flowrate changerequests, (iv) the software upgrades or downgrades, or (v) the filetransfers.

In accordance with a sixth aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the at least one operator input leading to the transmitted data concernsa water treatment device parameter.

In accordance with a seventh aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the at least one operator input leading to the transmitted data concernsa home therapy machine parameter, the transmitted data an automaticresult of a change in the home therapy machine parameter.

In accordance with an eighth aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects, ahome therapy medical system includes a home therapy machine forperforming a home therapy on a patient; a user interface operablyconnected to the home therapy machine, the user interface receivingoperator inputs; a water treatment device in fluid communication withthe home therapy machine; a server in data flow communication with thehome therapy machine; and a data connection between the home therapymachine and the water treatment device, wherein the home therapy machinetransmits data via the connection to the water treatment device, thedata based on a therapy prescription sent from the server to the hometherapy machine.

In accordance with a ninth aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the transmitted data is for control of the water treatment device.

In accordance with a tenth aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the therapy prescription specifies the data transmitted from the hometherapy machine to the water treatment device.

In accordance with an eleventh aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, the therapy prescription specifies an operating parameter forthe home therapy machine, the transmitted data based on the specifiedoperating parameter.

In accordance with a twelfth aspect of the present disclosure, which maybe used in combination with any one or more of the preceding aspects,the home therapy machine determines the transmitted data based on thespecified operating parameter.

In accordance with a thirteenth aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, the water treatment device uses the data to determine acorresponding operating parameter for the water treatment device.

In accordance with a fourteenth aspect of the present disclosure, whichmay be used in combination with any one or more of the preceding, theserver is configured to send a software upgrade to the home therapymachine, the software upgrade if meant for the water treatment deviceforwarded by the home therapy machine to the water treatment device.

In accordance with a fifteenth aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, the software upgrade is automatically installed on the watertreatment device or installed upon acceptance by a user via the userinterface.

In accordance with a sixteenth aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, the server is in data communication with a service computer,the service computer enabling a service person to access the watertreatment device via the data connection with the home therapy machineto perform at least one service procedure.

In accordance with a seventeenth aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, upon startup, the home therapy machine is configured todetermine if the water treatment device is in a hibernation mode and ifso to perform a startup procedure not involving the water treatmentdevice.

In accordance with an eighteenth aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, the home therapy medical system is configured to enable a uservia the user interface to run at least one self test for the hometherapy machine and at least one self test for the water treatmentdevice.

In accordance with a nineteenth aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, a home therapy medical system includes a home therapy machinefor performing a home therapy on a patient; a user interface operablyconnected to the home therapy machine, the user interface receivingoperator inputs; a water treatment device in fluid communication withthe home therapy machine; a server in data flow communication with thehome therapy machine; and a data connection device between the hometherapy machine and the water treatment device, wherein the watertreatment device is configured to transmit data via the data connectionto the home therapy machine, which forwards the data to the server.

In accordance with a twentieth aspect of the present disclosure, whichmay be used in combination with any one or more of the precedingaspects, the transmitted data includes treatment log data.

In accordance with a twenty-first aspect of the present disclosure,which may be used in combination with any one or more of the precedingaspects, the transmitted data includes component usage or componentreplacement data.

In accordance with a twenty-second aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 1 may be used in combination with any one or moreof the preceding aspects.

In accordance with a twenty-third aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 1A may be used in combination with any one or moreof the preceding aspects.

In accordance with a twenty-fourth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 2 may be used in combination with any one or moreof the preceding aspects.

In accordance with a twenty-fifth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 3 may be used in combination with any one or moreof the preceding aspects.

In accordance with a twenty-sixth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 4 may be used in combination with any one or moreof the preceding aspects.

In accordance with a twenty-seventh aspect of the present disclosure,any of the structure and functionality illustrated and described inconnection with FIG. 5 may be used in combination with any one or moreof the preceding aspects.

In accordance with a twenty-eighth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 6 may be used in combination with any one or moreof the preceding aspects.

In accordance with a twenty-ninth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 7 may be used in combination with any one or moreof the preceding aspects.

In accordance with a thirtieth aspect of the present disclosure, any ofthe structure and functionality illustrated and described in connectionwith FIG. 8 may be used in combination with any one or more of thepreceding aspects.

In accordance with a thirty-first aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 9 may be used in combination with any one or moreof the preceding aspects.

In accordance with a thirty-second aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 10A may be used in combination with any one or moreof the preceding aspects.

In accordance with a thirty-third aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 10B may be used in combination with any one or moreof the preceding aspects.

In accordance with a thirty-fourth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 11A may be used in combination with any one or moreof the preceding aspects.

In accordance with a thirty-fifth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 11B may be used in combination with any one or moreof the preceding aspects.

In accordance with a thirty-sixth aspect of the present disclosure, anyof the structure and functionality illustrated and described inconnection with FIG. 12 may be used in combination with any one or moreof the preceding aspects.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

The invention is claimed as follows:
 1. A peritoneal dialysis systemcomprising: a water treatment device including a water treatmentprocessor and a water treatment memory; a peritoneal dialysis (“PD”)machine including a PD processor and a PD memory, the PD machineconfigured to mix water treated by the water treatment device with atleast one concentrate to produce a peritoneal dialysis fluid fortreatment; and a data link between the water treatment processor and thePD processor, wherein (i) the PD processor uses instructions stored inthe PD memory to determine a treated water flowrate and send the treatedwater flowrate via the data link to the water treatment processor or(ii) the PD processor uses the instructions stored in the PD memory tosend a parameter via the data link to the water treatment processor,wherein the water treatment processor determines the treated waterflowrate from the parameter, and wherein the water treatment processorcauses the water treatment device to deliver treated water to the PDmachine at the treated water flowrate.
 2. The peritoneal dialysis systemof claim 1, wherein the treated water flowrate determined by the PDprocessor in (i) is retrieved from the PD memory of the PD machine. 3.The peritoneal dialysis system of claim 1, wherein the treated waterflowrate determined by the PD processor in (i) is a multiple of adialysis fluid flowrate.
 4. The peritoneal dialysis system of claim 1,wherein the treated water flowrate determined by the water treatmentprocessor in (ii) is a multiple of the parameter.
 5. The peritonealdialysis system of claim 1, wherein the treated water flowrate isadjustable over the treatment.
 6. The peritoneal dialysis system ofclaim 1, which includes a user interface enabling operation of both thewater treatment device and PD machine.
 7. A peritoneal dialysis systemcomprising: a water treatment device including a water treatmentprocessor and a first memory; a peritoneal dialysis (“PD”) machineincluding a PD processor and a second memory, the PD machine configuredto mix water treated by the water treatment device with at least oneconcentrate to produce a peritoneal dialysis fluid for treatment; a datalink between the water treatment processor and the PD processor; andwherein the water treatment device is configured to prepare an amount oftreated water and, upon communication between the water treatmentprocessor and PD processor over the data link, deliver the amount of thetreated water to the PD machine for use in mixing the peritonealdialysis fluid for the treatment, wherein the treated water has a puritycorresponding to an injectable quality or a sterile quality.
 8. Theperitoneal dialysis system of claim 7, wherein the PD processor controlsthe amount of treated water delivered to the PD machine bycommunicating, with the water treatment processor via the data link,when to start delivering the treated water to the PD machine and when tostop delivering the treated water to the PD machine.
 9. The peritonealdialysis system of claim 8, wherein the PD processor instructs the watertreatment processor to stop delivering the treated water when the amountof the treated water delivered to the PD machine reaches a predeterminedamount.
 10. The peritoneal dialysis system of claim 9, wherein thepredetermined amount corresponds to a volume level in a container. 11.The peritoneal dialysis system of claim 7, wherein the amount is apreset amount of treated water that corresponds to a volume of acontainer.
 12. The peritoneal dialysis system of claim 7, wherein the atleast one concentrate includes a dextrose or glucose concentrate. 13.The peritoneal dialysis system of claim 7, which includes a userinterface enabling operation of both the water treatment device and thePD machine.
 14. The peritoneal dialysis system of claim 7, wherein thedata link is wired or wireless.
 15. A peritoneal dialysis systemcomprising: a water treatment device including a water treatmentprocessor and water treatment memory storing first instructions foroperating the water treatment device; a peritoneal dialysis (“PD”)machine including a PD processor and PD memory storing a plurality ofprescriptions for peritoneal dialysis fluids and second instructions foroperating the PD machine so as to mix water treated by the watertreatment device with at least one concentrate to produce a peritonealdialysis fluid for treatment; and a data link between the watertreatment processor and the PD processor, and wherein the watertreatment processor is configured to receive, via the data link,information from the PD processor, wherein the information indicateswhich subset of instructions of the first instructions are to beexecuted by the water treatment processor, the subset of instructionscorresponding to one of the plurality of prescriptions for peritonealdialysis fluids.
 16. The peritoneal dialysis system of claim 15, whereinat least one of the first instructions or the subset of the firstinstructions is provided via the data link from the PD processor to thewater treatment processor.
 17. The peritoneal dialysis system of claim15, wherein at least one of the first instructions, second instructions,or the plurality of prescriptions are provided over a network from aremote source.
 18. The peritoneal dialysis system of claim 15, whereinthe first instructions specify a flowrate or volume of treated water todeliver from the water treatment device to the PD machine.
 19. Theperitoneal dialysis system of claim 15, wherein the first instructionsare derived from the plurality of prescriptions.
 20. The peritonealdialysis system of claim 15, which includes a user interface enablingoperation of both the water treatment device and the PD machine.